solid tumor
Conditions
Interventions
low dose group:The dosage for the patient each time is 500 billion cells per person per dose. First, receive a single dose of CEL001 injection (D1) and complete a 14-day safety observation period (sin
middle dose group:The dosage for the patient each time is 2 billion cells per person per dose. First, receive a single dose of CEL001 injection (D1) and complete a 14-day safety observation period (si
High Dose Group:The dosage for the patient each time is 5 billion cells per person per dose. First, receive a single dose of CEL001 injection (D1) and complete a 14-day safety observation period (sing
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be eligible for this study: 1.Age =18 years, regardless of gender. 2.ECOG performance status score: 0–1. 3.Histologically or cytologically confirmed advanced or metastatic solid tumors, with disease progression after standard therapy failure*, intolerance to standard therapy, or lack of effective treatment options, as defined by CSCO or NCCN guidelines. 4.Body weight:Male participants: =50 kg; Female participants: =45 kg 5.Expected survival >3 months. 6. At least one measurable lesion per RECIST v1.1 criteria. 7. Adequate organ function within 14 days prior to treatment initiation (no transfusion, long-acting EPO, or long-acting G-CSF within 14 days; if short-acting EPO/G-CSF was used, this window reduces to 7 days): 1) Hematology: Absolute neutrophil count (ANC) =1.5×10?/L Platelets =90×10?/L;Hemoglobin =90 g/L or =5.6 mmol/L 2) Renal function: Serum creatinine =1.5×ULN or Creatinine clearance (Ccr) =50 mL/min (calculated by Cockcroft-Gault formula) 3) Hepatic function: Total bilirubin =1.5×ULN (=5×ULN for hepatocellular carcinoma or liver metastases) AST/ALT =2.5×ULN (=5×ULN for hepatocellular carcinoma or liver metastases) 4) Coagulation: INR/PT =1.5×ULN,aPTT =1.5×ULN 8. Contraception requirements: Female participants: Negative serum pregnancy test within 7 days prior to enrollment, non-lactating, and must use effective contraception (e.g., IUD, oral contraceptives, or condoms) during the study and for 6 months after study completion. Male participants: Must use effective contraception during the study and for 6 months after study completion. * Definition of Standard Therapy Failure: Non-small cell lung cancer (NSCLC): Non-driver mutation metastatic disease: Disease progression after =2 prior lines (including platinum-based chemotherapy). *EGFR/ROS1/ALK-driven tumors*: Disease progression after targeted therapy followed by =2 lines (including platinum-based chemotherapy). Small cell lung cancer (SCLC): Progression after =2 prior lines. Colorectal cancer: Progression after =2 lines (prior regimens must include fluoropyrimidines, oxaliplatin, and irinotecan; BRAF V600E-mutated patients must have received BRAF inhibitors; MSI-H/dMMR patients must have received PD-1/PD-L1 therapy). Head and neck squamous cell carcinoma (HNSCC): Progression after =2 lines (including platinum-based chemotherapy). Urothelial carcinoma: Progression after =2 lines (including PD-1/PD-L1 inhibitors, platinum-based or taxane chemotherapy, enfortumab vedotin, or vinflunine; FGFR2/3-altered patients must have received erdafitinib). Esophageal cancer: Progression after =2 lines (including platinum-based chemotherapy). Cervical cancer: Progression after =2 lines (including platinum-based chemotherapy; PD-L1+/TMB-H/MSI-H/dMMR patients must have received PD-1/PD-L1 therapy). Hepatocellular carcinoma (HCC): Progression after =2 lines. Renal cell carcinoma (RCC): Progression after =2 lines. Other malignancies: Refer to the latest CSCO or NCCN guidelines.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will be excluded from this study: 1. Allergy to any component of CEL001 injection, including penicillin allergy. 2. Received chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or participated in other clinical trials within 4 weeks before the first dose or within 5 half-lives of the drug (whichever is shorter). 3. Treated with traditional Chinese medicine (TCM) or modern TCM preparations with approved antitumor indications within 14 days before the first dose. 4. History of other malignancies (except cured thyroid cancer, basal cell carcinoma, or cervical carcinoma in situ) within the past 5 years. 5. Adverse reactions from prior antitumor therapy have not recovered to NCI CTCAE v5.0 Grade =1 (excluding toxicities such as alopecia deemed non-risky by the investigator). 6. Underwent surgery within 4 weeks before treatment or has not fully recovered from prior invasive procedures. 7. Symptomatic CNS metastases, leptomeningeal metastases, or uncontrolled CNS lesions (investigator-assessed as ineligible). 8. Active infection (NCI CTCAE v5.0 = Grade 2) or other infection risks per investigator’s judgment. 9. History of autoimmune disease, immunodeficiency (including HIV-positive status), congenital/acquired immune deficiency, or organ transplantation. 10. Active hepatitis B or hepatitis C infection. 11.Prior immune cell therapy. 12. Severe cardiovascular disease, including: Clinically significant arrhythmias (e.g., ventricular arrhythmias requiring intervention, 2nd–3rd degree AV block). History of myocardial infarction, coronary artery bypass grafting (CABG), heart failure (NYHA Class II or higher), LVEF =50%, thrombosis, QTcF >450 msec (men) or >470 msec (women). History of stroke or severe cerebrovascular disease. 13.Concurrent antitumor therapies (e.g., radiotherapy, chemotherapy, immunotherapy, targeted therapy, or TCM). 14. History of neurological/psychiatric disorders (e.g., epilepsy, dementia). Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate and severity of treatment-related adverse events (AEs);Incidence rate and severity of treatment-related serious adverse events (SAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective Response Rate );DOR(Duration of Response);Progression Free Survival ;OS(Overall Survival );DCR (Disease Control Rate); | — |
Countries
China
Contacts
Public ContactNing Li
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed